Cell Therapy Society (ISCT) Supports Latest FDA Step In Assuring Safety of Cells and Tissues for Human Transplantation

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International Society for Cellular Therapy (ISCT) supports the intent behind the FDA's new rule on Good Tissue Practice. ISCT remains committed to facilitating supporting education and dialogue between industry and the FDA to ensure safe and effective pursuit of new cell and tissue-based therapies.

The International Society for Cellular Therapy (ISCT) (http://www.celltherapy.org) acknowledges the work of the U.S. Food and Drug Administration in today's issuance of the final rule on current good tissue practice (GTP) as part of the Agency's overall plan to ensure the safety of human cells and tissue products as they are used in the development of new therapies.

With 1 million cell transplants expected to be performed this coming year, ISCT supports the intent of the GTP rules in protecting public health. As one of the parent organizations of self-accrediting agencies such as the Foundation for the Accreditation of Cellular Therapies (FACT) (http://www.factwebsite.org), the Joint Accreditation Committee EBMT-EuroISCT (JACIE) (http://www.jacie.org/), and FACT's collaborative accrediting initiative with the NetCord Foundation (https://office.de.netcord.org/index.html), ISCT has been a leader in promoting standards and quality in cell and tissue transplantation.

ISCT will continue to work the Agency and industry in the pursuit of education, guidance, and dialogue to assist cell therapy facilities with compliance with the regulations such as this new rule.

"ISCT is pleased with all the effort this new rule represents both from within and without the FDA", says ISCT President, Dr. Donna Przepiorka, MD, PhD. "We look forward to continuing our role in facilitating education and dialogue between industry and the Agency as issues arise, clarification is sought, and guidance is developed around the regulatory framework of cell and tissue-based therapies that our research constituency is pursuing for the cure of currently incurable disease."


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